RS53257B2 - Lentiviralni vektori pseudotipizirani sa omotačem od glikobelančevine iz sindbis-virusa - Google Patents

Lentiviralni vektori pseudotipizirani sa omotačem od glikobelančevine iz sindbis-virusa

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Publication number
RS53257B2
RS53257B2 RS20140158A RSP20140158A RS53257B2 RS 53257 B2 RS53257 B2 RS 53257B2 RS 20140158 A RS20140158 A RS 20140158A RS P20140158 A RSP20140158 A RS P20140158A RS 53257 B2 RS53257 B2 RS 53257B2
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Serbia
Prior art keywords
lentiviral vector
virus
polypeptide
antigen
seq
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RS20140158A
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English (en)
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James M Allen
Hoeven Neal S Van
jin zhong Li
Derek D Sloan
Thomas W Dubensky Jr
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Immune Design Corp
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42727669&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=RS53257(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Immune Design Corp filed Critical Immune Design Corp
Publication of RS53257B publication Critical patent/RS53257B/sr
Publication of RS53257B2 publication Critical patent/RS53257B2/sr

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Claims (23)

  1. Patentni zahtevi 1. Čestice lentiviralnog vektora, naznačene time, što obuhvataju: (a) omotač koji se sastoji od (i) E2 glikobelančevine iz Sindbis-virusa sa SEQ ID BR: 1 gde 160X je odsutna ili je neka amino-kiselina koja je različita od glutaminske kiseline, ili od varijante SEQ ID BR: 1 koja ima najmanje 80% identičnosti sa SEQ ID BR: 1 i gde 160X je odsutna ili je neka amino-kiselina koja je različita od glutaminske kiseline, koja je sposobna da inficira dendrite; pri čemu E2 nije deo fuzione belančevine sa E3 iz Sindbis-virusa; i (b) genom lentiviralnog vektora koji obuhvata jednu ili više sekvenci od interesa.
  2. 2. Čestica lentiviralnog vektora iz zahteva 1, naznačena time, što je u njoj 160X odsutna ili je glicin, alanin, valin, leucin ili izoleucin, na primer je izabrana iz glicina, valina, leucina ili izoleucina.
  3. 3. Čestica lentiviralnog vektora iz zahteva 1 ili 2, naznačena time, što varijanta E2 glikobelančevine ima najmanje jednu amino-kiselinu koja je promenjena sa ciljem da se smanji njen neto pozitivni naboj.
  4. 4. Čestica lentiviralnog vektora iz zahteva 3, naznačena time, što najmanje jedna aminokiselina koja treba da se promeni sa ciljem da se smanji neto pozitivni naboj je izabrana iz lizina 70, lizina 76 ili lizina 159 iz SEQ ID BR: 1, pri čemu su supstitucije preferirano nezavisno izabrane iz glutaminske kiseline ili asparaginske kiseline.
  5. 5. Čestica lentiviralnog vektora iz zahteva 1, naznačena time, što sekvenca E2 varijante sadrži amino-kiselinske ostatke 66 do 488 iz SEQ ID BR: 3, amino-kiselinske ostatke 66 do 488 iz SEQ ID BR: 4, ili amino-kiselinske ostatke 66 do 486 iz SEQ ID BR: 5; (varijante 1, 2 i 3).
  6. 6. Čestica lentiviralnog vektora iz zahteva 1-5, naznačena time, što predstavlja varijantu u kojoj sekvenca sa ostacima 71-75 iz SEQ ID BR: 1 nije promenjena ili ima jednu ili dve supstitucije koje ne utiču na sposobnost pomenute varijante da inficira DC, ali ne menjaju broj amino-kiselina u tom regionu.
  7. 7. Čestica lentiviralnog vektora iz bilo kojeg od zahteva od 1-6, naznačena time, što sekvenca od interesa eksprimira produkt koji je antigen iz agensa koji uzrokuje bolest ili iz bolesne ćelije.
  8. 8. Čestica lentiviralnog vektora iz bilo kojeg od zahteva od 1-6, naznačena time, što sekvenca od interesa kodira tumor-specifični antigen, ponekad NY-ESO-1, MAGE, MART-l/Melan-A, BAGE, RAGE, antigen iz linije melanocitnog melanoma, poput gp 100, gp75, mda-7, tirozinaze ili belančevine slične tirozinaze; antigen iz karcinoma bubrežnih ćelija, 5T4, SM22-alfa, karbonsku anhidrazu I, kartonsku anhidrazu IX (takođe poznatu kao G250), faktore koji se induciraju hipoksijom (ponekad, HIF-1 alfa ili HIF-2alfa), VEGF ili membranski antigen specifičan za prostatu (PSMA), antigen specifičan za prostatu (PSA), fosfati prostatne kiseline, šest-transmembranski epoitelijalni antigen iz prostate (STEAP), NKX3.1, epitop belančevina/peptida koji su dobiveni iz gena koji mutiraju u tumorskim ćelijama ili gena koji se transkribiraju u drugačijim nivoima u tumoru u odnosu na normalne ćelije, poput encima telomeraze, survivina, mezotelina, mutiranog ras, bcr/abl rearanžmana, Her2/neu, mutiranog ili divljeg-tipa p53, citohroma P450 1B1 , nenormalno eksprimiranih intronskih sekvenca poput N-acetilglukozaminiltransferaze-V; klonalni rearanžmani imunoglobulinskih gena koji generišu jedinstvene idiotipove mijeloma ili limfoma B-ćelija; epitop belančevina/peptida koji su dobiveni tokom onkoviralnih procesa, poput belančevine E6 ili E7 iz humanog papiloma-virusa; ili ne-mutirane onkofetalne belančevine sa tumorselektivnom ekspresijom, poput karcinoembrionskog antigena ili alfa-fetobelančevine.
  9. 9. Čestica lentiviralnog vektora iz bilo kojeg od zahteva od 1 - 7 , naznačena time, što sekvenca od interesa kodira antigen izveden iz virusa, poput antigena iz HIV ili SIV, polipeptida adenovirusa, polipeptida alfavirusa, polipeptida kalicivirusa, tj., antigen iz kapsida kalicivirusa, polipeptida koronavirusa, polipeptida distemper-virusa, polipeptida Ebola- virusa, polipeptida enterovirusa, polipeptida flavivirusa, polipeptida hepatitis virusa (AE), tj., antigen iz srži ili površine hepatitisa B, ili belančevine El ili E2 iz virusa hepatitisa C, srž, ili ne-strukturne belančevine, polipeptida herpesvirusa, tj., glikobelančevine iz herpessimpleks virusa ili virusa varicella-zoster, polipeptida virusa imunodificijencije, tj., omotač ili proteaza iz virusa humane imunodificijencije, polipeptida virusa infektivnog peritonitisa, polipeptida virusa influence, tj., hemaglutinin, neuraminidazu iz influence A; ili nukleobelančevina, polipeptida iz virusa leukemije, polipeptida Marburg-virusa, polipeptida ortomiksovirusa, polipeptida papiloma-virusa, polipeptida virusa parainfluence, tj., hemaglutinin/neuraminidaza, polipeptida paramiksovirusa, polipeptida parvovirusa, polipeptida pestivirusa, polipeptida pikoma-virusa, tj., polipeptida iz kapsida poliovirusa, polipeptida poks-virusa, tj., polipeptida vakcinija-virusa, polipeptida virusa besnila, tj., glikobelančevina G iz virusa besnila, polipeptida reovirusa, polipeptida retrovirusa, ili polipeptida rotavirusa.
  10. 10. Kompozicija koja obuhvata česticu lentiviralnog vektora iz bilo kojeg od zahteva od 1-9, naznačena time, što sadrži IU od najmanje 10<5>/mL.
  11. 11. Sistem za pakovanje lentiviralnog vektora za proizvodnju pseudotipizirane čestice lentiviralnog vektora iz bilo kojeg od zahteva od 1-9, ili kompozicija iz zahteva 10, naznačeni time, što obuhvataju: (i) prvi molekul nukleinske kiseline koji kodira E2 glikobelančevinu iz Sindbis-virusa iz zahteva 1 (a)(i), i; (ii) drugi molekul nukleinske kiseline koji kodira gag- i pol-belančevinu, (iii) treći molekul nukleinske kiseline koji kodira rev; (iv) genom lentiviralnog vektora koji sadrži sekvencu od interesa; i (v) ćeliju za pakovanje.
  12. 12. Sistem za pakovanje lentiviralnog vektora iz zahteva l1, naznačen time, što: (a) pol-belančevina sadrži ne-funkcionalnu integrazu; i/ili (b) pol-belančevina sadrži ne-funkcionalnu integrazu sa D64V mutacijom; i/ili (c) genom lentiviralnog vektora je takav da ne može da se integriše; i/ili (d) ćelija za pakovanje je stabilno transformisana sa (ii) i (iii); i/ili (e) ćelija za pakovanje je transformisana sa (i) i (iv).
  13. 13. Izolovan molekul nukleinske kiseline, naznačen time, što obuhvata nukleotidnu sekvencu koja kodira E2 glikobelančevinu ili varijantu iz zahteva 1 (a)(i), ili bilo kojeg od zahteva od
  14. 14. Molekul nukleinske kiseline iz zahteva 13, naznačen time, što pomenuta belančevina je E3/E2/6K/El-polibelančevina iz Sindbis-a koja se obrađuje na način da E2 belančevina nije deo fuzione belančevine sa E3 kada se ugradi u viralni omotač.
  15. 15. Molekul nukleinske kiseline iz zahteva 14, naznačen time, što E3 sekvenca odgovara (a) ostacima 1-65 iz SEQ ID BR: 20, ili (b) njena varijanta ima najmanje 80% identičnosti sa ostacima 1-65 iz SEQ ID BR: 20, pri čemu ostaci 62-65 su RSKR (SEQ ID BR: 27), a pomenuta varijanta je sposobna da se ugradi u pseudotipizirani viralni omotač.
  16. 16. Postupak za proizvodnju čestice lentiviralnog vektora iz bilo kojeg od zahteva od 1-9, ili kompozicija iz zahteva 10 koja sadrži kultiviranje lentiviralnog sistema iz zahteva 11.
  17. 17. Lentiviralna čestica iz bilo kojeg od zahteva od 1-9, ili kompozicija iz zahteva 10, naznačeni time, što genom lentiviralnog vektora (a) sadrži inaktivisano ili samo-inaktivirajuće 3' dugo terminalno ponavljanje (LTR); i/ili (b) obuhvata U3-element kojemu nedostaje najmanje: (i) sekvenca-pojačivač; (j) (ii) TATA-kutija (iii) Sp 1-mesto (iv) NK-kapa B-mesto i (v) polipurinski trakt (PPT); i/ili (c) obuhvata nukleotidnu sekvencu iz SEQ ID BR: 21, 22 ili 23; i/ili, (d) obuhvata nukleotidnu sekvencu koja kodira faktor za sazrevanje/stimulisanje dendrita.
  18. 18. Čestica lentiviralnog vektora u skladu sa bilo kojem od zahteva od 1-9, ili kompozicija iz zahteva 10, naznačeni time, što se koriste u postupku za tretman ljudskog ili životinjskog subjekta, pri čemu tretman ponekad obuhvata dostavu čestica lentiviralnog vektora u dendrite ex vivo.
  19. 19. Čestice lentiviralnog vektora prema bilo kojeg od zahteva od 1-9, ili kompozicija iz zahteva 10, naznačeni time, što se koriste za indukovanje antigen-specifičnog imuno odgovora, ponekad humoralnog odgovora i/ili ćelijskog odgovora.
  20. 20. Terapeutsku ili profilaktičku vakcinu, naznačena time, što obuhvata čestice lentiviralnog vektora iz bilo kojeg od zahteva od 1-9, ili kompoziciju iz zahteva 10, i neki farmaceutski prihvatljivi ekscipijent.
  21. 21. Terapeutska ili profilaktička vakcina u skladu sa zahtevom 20, naznačena time, što dodatno obuhvata neki dodatak.
  22. 22. Terapeutska ili profilaktička vakcina u skladu sa zahtevom 21, naznačena time, što pomenuti dodatak je neki dodatak sa formulom (I):
    gde Al i A2 su nezavisno izabrani iz grupe koja obuhvata vodonik, fosfat, i fosfatne soli, a ostaci R<1>, R<2>, R<3>, R<4>, R<5>i R<6>su nezavisno izabrani iz grupe ugljovodonika koji imaju 3 do 23 ugljenika, a su predstavljeni sa<C3-C23.>
  23. 23. Terapeutska ili profilaktička vakcina u skladu sa zahtevom 22, naznačena time, što (a) Al je fosfat ili fosfatna so, a A2 je vodonik, i (b) (i) R<1>, R<3>, R<5>i R<6>su C<11>-C<20>alkil, a R<2>i R<4>su C<12>-C<20>ugljovodonik; ili (ii) R<1>, R<3>, R<5>i R<6>su C11alkil, a R<2>i R<4>su C<13>ugljovodonik; ili (iii) R<1>, R<3>, R<5>i R<6>su undecil, a R<2>i R<4>su tridecil. Izdaje i štampa: Zavod za intelektualnu svojinu, Beograd, Kneginje Ljubice 5
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